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临床试验/JPRN-UMIN000011279
JPRN-UMIN000011279已完成未知

Independent study: Researching drug-drug interaction bitween etizolam and itraconazole - Independent clinical study (University of Tokyo)

P-One Clinic, Keikokai Medical Corp0 个研究点目标入组 16 人开始时间: 2013年7月26日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
16

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 35years-old(—)
性别
Male

入选标准

  • 未提供

排除标准

  • a) Has hypotension (blood pressure of less than 100 mmHg during systole), hypertension (blood pressure of 140 mmHg or higher during systole) or diabetes (HbA1c NGSP 6.5% or higher). b) Has donated or lost over 200 ml (1 unit) of blood within four weeks prior to study drug administration or 400 ml (2 units) within 3 months, or is anemic (less than Hb 12 g/dl). c) Has a serious neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, digestive tract (including digestive tract disorders thought to impact trial drug absorption), respiratory, or metabolic disease in their medical history or as a concomitant condition. d) A clinically serious abnormality has been found by the principal investigator or one of the subinvestigators in the clinical test values, ECG or physical examination. e) Had a clinically serious illness within 30 days prior to study drug administration. f) Has used some sort of health food, grapefruit (including food containing it), or medical product within seven days prior to study drug administration or will use it during the study period. g) Has smoked tobacco or ingested nicotine within 30 days prior to study drug administration and, moreover, cannot abide by the prohibition on smoking during the study period. h) Cannot abide by the ban on caffeine and alcohol during the study period. i) Tested positive for a specific abused substance in the urine drug test at the screening. j) Tested positive for either HIV antibodies/antigens, HCV antibodies, or HBs antigens. 15) Anything else that the principal investigator or one of the subinvestigators considers to be disqualifying.

研究者

发起方
P-One Clinic, Keikokai Medical Corp

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